Quality assurance and quality control in the laboratory andrology

Quality assurance （QA） and quality control （QC） are fundamental aspects of any laboratory measurement. However, in comparison with other medical disciplines, the need for QA and QC in laboratory andrology has been recognized only recently. Furthermore, there is evidence that the effort required to undertake QA and QC has not been wholly welcomed by some clinicians. Nevertheless, accrediting bodies and regulatory authorities increasingly require evidence that laboratories have effective QA and QC measures in place because both are central to the quality management processes. Following the publication of the 5th edition of the World Health Organization Laboratory Manual, existing QA and QC systems will need to be updated to take into account some of the methodological changes recommended by the manual. Three of these are discussed in this commentary; they relate to： （i） the move to infer semen volume from its weight; （ii） the re-classification of sperm motility grades from four to three; and （iii） the publication of a lower reference limit for morphology of 4% （with a corresponding 95% confidence interval of 3%-4%）. The importance of QA and QC in all laboratory tests, including up and coming new tests to assess sperm DNA integrity, is discussed. The need for adequate initial training and continuing professional development programmes to support laboratory scientists performing andrology is also described.

Dynamic estimation and reliability control of quality assurance for bored piles

A systematic method was proposed to estimate the occurrence probability of defective piles(OPDP) from a site according to quality assurance inspection. The OPDP was firstly suggested as the criterion to weight the performance of a pile foundation. Its prior distribution and updating distribution were deduced to follow Beta distributions. To calibrate the OPDP, a dynamic estimation model was established according to the relationships between prior mean and variance and updating mean and variance. Finally, a reliability-control method dealing with uncertainties arising from quality assurance inspection was formalized to judge whether all the bored piles from a site can be accepted. It is exemplified that the OPDP can be substantially improved when more definite prior information and sampling formation become available. For the example studied herein, the Bayesian estimator of updating variance for OPDP is reduced from 0.0037 to 0.0014 for the first inspection, from 0.0014 to 0.0009 for the second inspection, and with less uncertainty by incorporating experience information.

Development and Challenge of HIV/AIDS Testing Laboratory Network and Quality Assurance System in China

This paper describes the development and challenge of HIV/AIDS testing laboratory network and quality assurance system in China. At present,the HIV/AIDS testing laboratories includes three classes,the National AIDS Reference Laboratory,HIV/AIDS confirmatory laboratories and HIV/AIDS screening laboratories. All of them are accredited by the health authorities,and each class of laboratories take charge of their function strictly according to the "National Management of HIV/AIDS Detection (2006)". A complete quality assurance and quality control system for HIV/AIDS testing has been developed,which includes technical training,strict laboratory monitoring and approval,examination or proficiency testing on HIV/AIDS detection,and quality evaluation and supervision of HIV/AIDS diagnostic kits. Besides conduct the routine anti-HIV antibody test,more and more laboratories began to conduct other tests,such as CD4+ T lymphocyte cell counting,HIV viral load,HIV DNA PCR,genotyping,drug resistance,and HIV-1 recent infection test. The primary challenges faced by the HIV/AIDS testing laboratory network are in the areas of laboratory management and quality control. For example,the provincial PT program is inefficient,the internal quality control is conducted perfunctorily,personnel training can not met the needs of the workplace,which need to be improved.

Application of Statistical Process Control for Setting Action Thresholds as Quality Assurance of Dose Verifications in External Beam Radiotherapy

Purpose: To test the concept of Statistical Process Control (SPC) as a Quality Assurance (QA) procedure for dose verifications in external beam radiation therapy in conventional and 3D Conformal Radiotherapy (3D-CRT) treatment of cervical cancer. Materials and Methods: A study of QA verification of target doses of 198 cervical cancer patients undergoing External Beam Radiotherapy (EBRT) treatments at two different cancer treatment centers in Kenya was conducted. The target doses were determined from measured entrance doses by the diode in vivo dosimetry. Process Behavior Charts (PBC) developed by SPC were applied for setting Action Thresholds (AT) on the target doses. The AT set was then proposed as QA limits for acceptance or rejection of verified target doses overtime of the EBRT process. Result and Discussion: Target doses for the 198 patients were calculated and SPC applied to test whether the action limits set by the Process Behavior Charts could be applied as QA for verified doses in EBRT. Results for the two sub-groups of n = 3 and n = 4 that were tested produced action thresholds which are within clinical dose specifications for both conventional AP/PA and 3D-CRT EBRT treatment techniques for cervical cancer. Conclusion: Action thresholds set by SPC were within the clinical dose specification of ±5% uncertainty for both conventional AP/PA and 3D-CRT EBRT treatment techniques for cervical cancer. So the concept of SPC could be applied in setting QA action limits for dose verifications in EBRT.

Study on Factors Influencing the Quality of Automatic Monitoring Data of Pollution Sources and Technical Assurance Measures

Automatic monitoring data of pollution sources is an important basis for environmental supervision and management.At present,it is difficult to guarantee the quality of automatic monitoring data of pollution sources,and it is difficult to play the role of the monitoring data.In response to this problem,the factors influencing the quality of automatic monitoring data of pollution sources were analyzed in detail,and technical assurance measures for the quality of automatic monitoring data of pollution sources in Shandong Province were studied.Besides,the dynamic management and control idea of automatic monitoring of pollution sources was proposed,and specific technical measures were analyzed from five aspects of standardizing automatic monitoring equipment of pollution sources,improving the data collection and transmission system,establishing a mechanism for reporting operating status information of monitoring equipment,setting alarm rules and alarm processing procedures,and statistically analyzing the operating status of the equipment.Practice has proved that the dynamic management and control system can effectively ensure the quality of automatic monitoring data of pollution sources.

QUALITY ASSURANCE INFORMATION SYSTEM FOR AGILE MANUFACTURING

The customer driven dynamic global market and geographical distribution of collaborating partners bring new challenges to the development of quality assurance information system (QAIS) for agile manufacturing. With recent dramatic advances in information technology, firstly the requirements of QAIS are examined in agile manufacturing environment, then a new implementation framework of a distributed QAIS is presented, where a deve loping environment of QAIS is established and some critical techniques are studied. Finally a prototype system based on world wide web (WWW) is accomplished.

Influence of quality assurance on patients dose reduction in some hospitals

The radiation dose received by patients undergoing chest radiography was included. 200 patients who attended these investigations in 10 hospitals in Iran were randomly selected from all ages groups and both female and male. Critically ill patients were excluded. This paper presents the work, which was implemented on 200 patients and evaluated using the entrance skin dose （ESD） in the posterior anterior （PA） chest projection measured directly at the center of the X-ray field. In addition, the machine room, and dark room .parameters, as well as work practices and repeat rates were studied. The quality control （QC） parameters and the ESD before and after QC were evaluated utilizing an anthropomorphic phantom to define the optimal exposure condition at all hospitals. This research shows that after using the QC parameters and after optimization of the exposure conditions, the ESD was decreased by 42% on average. Also the qua/ity of the radiographs generally increased. The reported method is easily implemented in any clinical situation where optimization of chest radiography is needed.

Replacing liquid fyrite with digital to improve <i>in vitro</i>fertilization laboratory quality control procedures

In clinical in vitro fertilization (IVF), optimal culture conditions are required for production of high quality embryos and for achieving high pregnancy rates. Cell culture systems require vigilant attention to quality control and quality assurance, and upgrades to equipment and procedures require strenuous deliberation. During a 2-week maintenance period, we undertook an extensive analysis of incubator carbon dioxide (CO2) monitoring and the effect on culture media pH by comparing our traditional liquid Fyrite instruments to a certified and calibrated digital CO2 analyzer. The digital analyzer produced consistently lower CO2 readings and significantly greater precision than the liquid Fyrite. Media pH measurements showed significant variation depending on CO2 calibration device;however pH remained within manufacturers’ specifications. After superior performance by the digital analyzer, we incorporated this device into the incubator calibration and daily quality control procedures. A retrospective comparison of overall lab performance before and after this equipment switch demonstrated improved clinical pregnancy and implantation rates. This report illustrates the necessary caution when altering established laboratory procedures and equipment while highlighting the benefits of judiciously updating techniques and equipment in a laboratory setting that is often stubborn to change pre-existing, ingrained methodology.

城市污水中PCBs的分析及其QA/QC研究

报道了一种城市污水中痕量PCBs的分析方法,并进行了QAQC研究,采用二氯甲烷萃取剂对城市污水进行液_液萃取,联合运用浓硫酸和硅胶层析柱将PCBs与杂质分离,以毛细管GC_ECD和内标法对PCBs定量。空白加标回收试验得出,PCBs的回收率为58%～125%,标准偏差为0.00173～0.00778μgL,相对标准偏差为1.58%～12.43%。以实际城市污水作为加标基质,得出加入污水中的19种PCBs的分析方法回收率为57.6%～129.2%,方法的检测限为0.010～0.056μgL,满足了USEPA对PCBs回收率要求。经过3次平行测定,测得实际城市污水中PCBs含有9种PCBs,PCBs总量的平均值为0.0235μgL,相对标准偏差为9.63%,该分析方法所需的仪器简便、容易操作。

QA/QC措施在中哈有机氯农药联合监测工作中的应用

为了说清伊犁河出、入境断面六六六、DDT等4种有机氯农药的检出问题,中国与哈萨克斯坦双方分别在中方的三道河子断面和哈方的杜本断面进行了联合研究性监测。中方采取现场采集平行样并加带全程序空白样品,实验室采用溶剂空白、实验室空白、全程序空白、平行双样以及加标回收分析等质控措施,使哈方专家认可中方监测数据的准确性和有效性,保证了双方的监测结果被中哈环保合作委员会接受和采用。研究以中哈跨界河流实际监测的典型实例,论证了质量保证与质量控制措施(QA/QC)在跨国界河流联合监测工作中的重要作用。

浅谈医疗设备的QA、QC与医疗质量的关系

医疗设备的质量保证(QA)与质量控制(QC)是医院医疗质量管理的一项重要内容。文章阐述了医疗设备QA、QC的重要性及其主要做法。

城市污水污泥中PCBs的分析及其QA/QC研究

采用正己烷/丙酮混合萃取剂索氏提取污泥,浓硫酸洗涤和硅胶层析柱净化分离出纯净的PCBs,以毛细管GC-ECD和内标法对PCBs定量,并进行了QA/QC研究.以实际城市污水污泥作为加标基质,方法的检测限为0·92—2·82ng·g-1(干重),19种PCBs同族体的回收率为54·2—140·6%,相对标准偏差为6·5—15·3%,满足US EPA对PCBs回收率的要求.经过3次平行分析,城市污水污泥中含有12种PCBs,PCBs总量的平均值为115·73ng·g-1(干重),相对标准偏差为9·57%.

美国环境监测QA/QC的进展及对我们的启示

本文着重介绍质量保证与质量控制在环境监测中(特别是有机物监测中)应用的意义。美国环境保护部门对质量保证与质量控制是如何认识和行动的,我国环境保护部门对质量保证与质量控制的认识,以及本文作者分别就自己的经验谈对QA/QC的体会,和在监测科研中对我国各级环境监测实验室推行QA/QC的建议。

逐步回归在评价水质监测采样过程QC/QA中的运用

评价监测采样过程ＱＣ／ＱＡ的优劣的方法并不多见，本文试图通过逐步回归的方法来探讨特定水质监测对象监测采样过程ＱＣ／ＱＡ的评价问题。

Partial Quality Assessment of ⁶⁰Co-Teletherapy Machine Performance

The aim of this study was to assess the performance of 60Co-teletherapy unit at Radiation and Isotopes Center in Khartoum, using the common tools used for quality control (Front pointer, Graphic paper, Pin, Non-screen film, meter and Check plate). The collected and analyzed data revealed that: there was a difference between the calculated theoretical field size (FS) and the measured one relative to the change of SSD;and the average FS shift was 0.9 cm relative to the standard one, while the machine isocenter was almost fixed at 0° with a shift of 0.003 cm, which was within the standard limit (0.2 cm). The diaphragm isocenter showed a shift of ±0.36 cm (i.e. in clock and anti clock wise) in average relative to standard limit (±0.3 cm) and the couch vertical isocenter (CVI) relative to the SSD changes was exceeded the standard limit (0.2 cm) by a factor of 0.9 cm. Also the SSD determined by the optical distance indicator was greater than the actual SSD (determined by Front pointer and measured by scale meter) by an average of 0.8 cm;which exceeded the limit (0.3 cm) by an average factor of 0.5 cm. The study also showed that the penumbra profile (1.5 cm) was less than the actual specified for 60Co-teletherapy machine, while the radiation beam was so homogeneous across the field size.

QC与QA职能初步比较对就业规划的启示

本文采用实地调研、亲身实践与查阅文献相结合的方式,基于工作内容及工作依据两部分,对制药企业QC、QA岗位职能进行了初步比较分析。分析结果显示从药企入职的非熟练人员到工程师,其首要任务是必须系统、全面地学习并熟练掌握药品生产全过程质量控制中QC和QA两大职能的理论知识和技术运用。通过对比制药企业质量控制(QC)和质量保证(QA)职能,为准备从事QC或QA的药学专业大学毕业生进入制药企业职业规划提供建议参考,即大学毕业生想成为一名合格的制药企业QC或QA人员,详尽的3~5年从基层开始职业规划尤为重要。

Management System Activities of the Operation and Utilization of GHARR-1

The Ghana Research Reactor-1 (GHARR-1) is a 34 kW low enriched uranium (LEU) Miniature Neutron Source Reactor (MNSR), tank-in-pool type and cooled by natural circulation under atmospheric pressure operating conditions. GHARR-1 is owned by Ghana Atomic Energy Commission (GAEC) and operated by National Nuclear Research Institute (NNRI), one of the institutes of GAEC. GHARR-1 is housed by Nuclear Reactors Research Centre (NRRC), one of the Centres of NNRI. Management/Administration, Radiation protection, Reactor operation and maintenance, Reactor utilization and Physical protection are the various systems/units that integrate to manage the activities of operation and utilization of GHARR-1 in addition to the quality assurance and quality control management system of the research reactor facility. The GHARR-1 which is currently in operation follows a robust maintenance culture adopted by the management system and this has made it possible to keep the reactor in operation with minimal interruption. The management system activities adopted at the Centre to ensure safety of the workers, public and the research reactor facility include authorization of the operation of the reactor for any experiments/modifications;providing material and financial resources for maintaining the research reactor facility;following standard procedures while carrying out Neutron Activation Analysis;participation in IAEA proficiency test;irradiation sites/positions characterization;following standard procedures while carrying out reactor operation and maintenance including reactor and pool water purification and other related activities;monitoring radiation levels in the controlled, supervised and uncontrolled areas of the research reactor facility as well as during reactor operation and maintenance;controlling the physical entry of the workers and public into the research reactor facility;and ensuring that the security structures provided to protect the reactor facility are functioning properly. The thorough knowledge on the functions of the various components that make up the electrical/electronic and control systems of the reactor has been observed to be important for continuous successful maintenance of the research reactor to keep the reactor in operation. This work provides some management system activities adopted to monitor the activities of the research reactor operation and utilization to guarantee safety of workers, public and the environment as well as to safeguard a continuous operation of the research reactor. These management system activities adopted among others, are in the form of Monitoring Forms provided for monitoring the activities of the research reactor operation and utilization in order to ensure standard procedures and specifications are followed and quality services are rendered to the public.

Top-down法评定EDTA络合滴定法测定海洋沉积物中碳酸钙含量的不确定度

依据Top-down技术中的质控图法对EDTA络合滴定法测定海洋沉积物中碳酸钙含量的不确定度进行评定。利用2021年质控样标准物质GBW 07333、GBW 07314和GBW 07316中CaCO_(3)测定值的时序数据进行评定,3组时序数据正态统计量A^(2*)(s)和独立性统计量A^(2*)(RM)均小于1,CaCO_(3)测定值、A_(EWMi)和移动极差控制图没有失控点,3组时序数据处于受控状态。当CaCO_(3)质量分数分别为2.05%、6.20%和38.56%时,计算得其扩展不确定度分别为0.08%、0.07%和0.20%。将测量不确定度与对应含量值进行线性拟合建立了不确定度预测模型,GBW 07309和GBW 07334中CaCO_(3)的测量不确定度预测值分别为0.09%和0.18%,预测值与Top-down技术获取的评定结果较为吻合。

水生生物监测质量保证、质量控制与标准化:动态与展望

水生生物监测是流域水生态状况评价的重要基础,监测数据的准确性和可靠性直接影响水生态环境质量评价与流域水生态管理成效。目前我国水生生物监测质量保证和质量控制体系尚处于持续完善的阶段,关键环节的控制要求和质控目标等亟待明确和细化。本文总结了欧美发达国家水生生物监测质量保证与质量控制体系建设中的经验,通过梳理我国水生生物监测工作基础与进展,较为系统地提出了适合我国现状的水生生物监测质量保证与质量控制体系标准化建设对策建议,包括实验室内部和外部质量保证与质量控制、水生生物监测质控数据库、人工智能识别和环境DNA新技术质控要点等标准化建议,为实现水生生物监测业务化运行,准确评估我国流域水生态质量状况的变化提供技术支撑。